MedTrace Logo

Evaluation of Safety, Rate and Extent of Absorption of Psilocin Mucate

NCT06035900 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-09-13

No results posted yet for this study

Summary

Psilocin is the active metabolite of psilocybin a natural material found in several types of fungi. The bioavailability of psilocybin, the prodrug of psilocin, has been reported to be over 60%. However, pharmacokinetics and bioavailability of psilocin mucate has not been reported. This Phase I "First in Man" study of psilocin mucate is designed to determine its safety, pharmacokinetics, and bioavailability. The study is conducted under the supervision of physicians and psychiatrists who also will administer a mini-mental state evaluation and report observable anti-anxiolytic effect of the dosage. Safety and possible indications of efficacy will be tracked during the study period, a week following the dose administration and one month after.

Conditions

  • Side Effect of Drug

Interventions

DRUG

Psilocin

single 4mg dose of psilocin mucate was administered to healthy 10 volunteers

Sponsors & Collaborators

  • Pharmaceutical Research Unit, Jordan

    collaborator OTHER

  • Lobe Sciences Ltd.

    lead INDUSTRY

Principal Investigators

  • Ahmad Abdulkhaleq, MD · Arab Pharmaceutical Industry Pharmaceutical Research

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-21
Primary Completion
2023-07-30
Completion
2023-07-30

Countries

  • Jordan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06035900 on ClinicalTrials.gov